Positive results from Clermont's non-preserved latanoprost phase III trial on glaucoma

Sep 26 2011

Clermont Pharmaceuticals, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today positive results from a phase III trial of non-preserved latanoprost. In the study, non-preserved latanoprost was compared to Xalatan® (latanoprost ophthalmic solution) 0.005%, in subjects diagnosed with open-angle glaucoma.  Non-preserved latanoprost achieved the primary efficacy endpoint of non-inferiority to Xalatan.  In addition, non-preserved latanoprost was better tolerated than Xalatan, with statistically fewer ocular symptoms on instillation and significantly fewer subjects with conjunctival hyperemia.  Xalatan is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension; it was approved by the US Food and Drug Administration for use in 1996.  Xalatan is the registered trademark of Pfizer, Inc. 

Clermont obtained the US rights to non-preserved latanoprost from Laboratoires Thea S.A.S, an ophthalmic pharmaceutical company based in France.  Laboratoires Thea recently filed an application for European marketing authorization with the EMEA. 

Based on these positive results, Clermont intends to file a New Drug Application with the US FDA in the fourth quarter of 2011.  Clermont plans to begin discussions with potential marketing partners in the near future.